TABLE 3.
Comparison of serum tenofovir PK for healthy young men administered multiple doses of TDF with and without raltegravira
| Treatment | GM (CI) for parameter (n = 9):
|
|||
|---|---|---|---|---|
| C24 (ng/ml)b | AUC0-24 (ng h−1/ml)b | Cmax (ng/ml)b | Tmax (h) | |
| Tenofovir alone (95% CI) | 34.4 (28.0-42.3) | 1,737 (1,485-2,032) | 263 (223-311) | 0.5c |
| Tenofovir + raltegravir (95% CI) | 29.9 (24.3-36.8) | 1,563 (1,336-1,828) | 202 (171-239) | 1.0c |
| Tenofovir + raltegravir-tenofovir ratio (90% CI) | 0.87 (0.74-1.02) | 0.90 (0.82-0.99) | 0.77 (0.69-0.85) | 0.3 (0.0-0.8)d |
| P | 0.137 | 0.067 | 0.001 | 0.883 |
a
Subjects were administered multiple doses of TDF at 300 mg once daily with and without raltegravir at 400 mg twice daily.
b
The GM was computed from the least-squares estimate from an ANOVA performed on the natural-log-transformed values.
c
Median reported for Tmax.
d
Hodges-Lehman estimate of median treatment difference and 90% CI for true median treatment difference.